Effect of Administration of Combined Enteral Lactoferrin and Probiotic On Invasive Fungal Infections In Preterm Neonates

Fungal Infection Clinical Trial

Official title:

Effect of Administration of Combined Enteral Lactoferrin and Probiotic On Invasive Fungal Infections In Preterm Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05283278
• Other study ID #: Pediatrics Dep-ASU
• Status: Completed
• Phase: Phase 1
• Start date: February 10, 2020
• Est. completion date: April 27, 2021

Study information

• Verified date: March 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The risk for invasive fungal infections is high in very low birth weight (VLBW) infants (< 1500 g) and highest for infants born at the youngest gestational ages who survive past the immediate postnatal period.

Invasive fungal infections (IFIs) represent an increasing cause of severe morbidity and mortality in most neonatal intensive care units.

Lactoferrin (LF) is secreted by epithelial cells into exocrine fluids: seminal fluid, tears, saliva, uterine secretions, and milk. LF is involved in innate immunity mechanisms with several documented anti-infective properties, including antifungal activity.

Probiotics are microorganisms that are believed to provide health benefits when consumed.

It is possible to adopt measures to modify the flora in our bodies and to replace the harmful microbes by useful microbes.

There are certain commercially available strains of probiotic bacteria from the Bifido bacterium and Lactobacillus genera when taken by mouth in daily doses possess treatment efficacy

Description:

Bovine LF alone or in combination of probiotics (Lactobacillus Delbrueckii and Lactobacillus Fermentum) can be used in prevention of invasive fungal infection in preterm neonates admitted to the NICU. So, this randomized interventional study aimed at evaluation of the efficacy and safety of enterally administered bovine LF alone or in combination of probiotics (Lactobacillus Delbrueckii and Lactobacillus Fermentum) in comparison to placebo in preterm neonates, through studying blood culture for fungal infection at enrollment, day 7, 14, 21 and 28 using Sabouraud agar for detecting Candida species and Hichrome agar to detect other fungal types ( primary outcome), and to compare length of hospital stay (LOS), use and duration of drug intake as antibiotics and inotropes, use and duration of mechanical ventilation, rate of increase of enteral feeding, time to reach full enteral intake, signs of feeding intolerance, complete blood count (CBC), C reactive protein (CRP), packed red blood cell transfusion (PRBCs) and mortality between the 3 groups as (secondary outcome).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 27, 2021
• Est. primary completion date: March 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

Inclusion Criteria:

• 80 preterm

• = 36 weeks gestational age

• >/ = 72 hours of life

Exclusion Criteria:

1. Nothing per os

2. Congenital anomalies.

3. Suspected inborn error of metabolism.

4. Prophylaxis antifungal drugs

Related Conditions & MeSH terms

• Communicable Diseases
• Fungal Infection
• Infections
• Invasive Fungal Infections
• Mycoses

Intervention

Drug:
• Lactoferrin Bovine
Lactoferrin granules (Pravotin®) in a dose of 100 mg /kg/day starting from birth to the 30th day of life for neonates in group A

Combination Product:
• Lactoferrin Bovine and probiotics
Lactoferrin granules (Pravotin®) in a dose of 100 mg /kg/day in combination with the probiotic Lactobacillus Delbrueckii and Lactobacillus Fermentum (Lacteol fort®) given in a dose of 5 billions starting from birth to the 30th day of life for neonates in group B

Other:
• Placebo
Placebo will be given starting from birth to the 30th day of life for neonates in group C.

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with invasive fungal infection (IFI)	Efficacy of enteral lactoferrin either alone or in combination with the probiotic Lactobacillus Delbrueckii and Lactobacillus Fermentum in the prevention of invasive fungal infections in preterm infants through analyzing the incidence rates of invasive fungal infection (IFI) in all groups using Sabouraud agar for detecting Candida species and Hichrome agar to detect other fungal types.	12 months
Secondary	Number of patients who received packed RBC in each group	The number of patients who received packed RBC in each group from time of enrollment till the 30th day of life	30 days
Secondary	Days on inotropic support in each group	Define how many days required for inotropic support in each group	12 months
Secondary	Days on mechanical ventilation in each group	Define how many days required for mechanical ventilation support in each group	12 months
Secondary	Days of NICU admission in each group	Define how many days patients in each group were admitted in the NICU	12 monthes
Secondary	Number of participants with Necrotizing enterocolitis in each group	Define the rate of NEC occurrence in each group	12 months
Secondary	Mortality in each group	Define the number of mortality in each group	12 months